BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 3849564 · Received June 4, 2014

    Report

    Report Number
    3849564
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 22, 2014
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION ON (B)(6) 2014, THERE WAS SHEARING OFF OF THE... THE FRAGMENT WAS RETRIEVED ON (B)(6) 2014. WHILE USING FLUOROSCOPY FOR GUIDANCE, THE TIP OF A LARGE CALIBER SPINAL NEEDLE WAS PLACED WITHIN THE THECAL SAC VIA A LEFT L2/L3 INTERLAMINAR APPROACH. CSF WAS OBTAINED. INITIALLY LUMBAR DRAIN WAS INSERTED THROUGH THE SPINAL NEEDLE AND EXTENDED SUPERIORLY TO APPROX THE T10 LEVEL, BUT WOULD NOT ADVANCE FURTHER; THE CATHETER SEEMED TO TURN BACK ON ITSELF; IT WAS AT THAT INSTANT THAT THE WIRE TO THE DRAIN WAS VISIBLE OUTSIDE THE NEEDLE. THIS CATHETER WAS REMOVED. THE SECOND LUMBAR DRAIN WAS INSERTED THROUGH THE SPINAL NEEDLE AND WAS ABLE TO BE SUCCESSFULLY TRAVERSED SUPERIORLY UP THE THECAL SAC TO THE MID T7 LEVEL. SPINAL NEEDLE WAS REMOVED. PT TOLERATED PROCEDURE WELL. AT THE END OF THE PROCEDURE APPROX 15CM OF THE INITIAL LUMBAR DRAIN WAS NOTED TO BE SHEARED OFF AND LIKELY LOCATED WITHIN THE PT'S THECAL SAC. CT SCAN SHOWED LUMBAR DRAIN ENTERING AT L2-L3 LEVEL AND TIP AT L7. A FRAGMENTED LUMBAR DRAIN WAS SEEN AT THE T10 TO L3 LEVEL ON THE RIGHT. ON (B)(6) 2014, PT HAD SURGERY TO REMOVE THE INTRATHECAL CATHETER FRAGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327112 MEDTRONIC LUMBAR CATHETER JXG D58054 (PROBABLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR